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Industry Gives Big Money To GOP Senators Backing Device Reforms, But Buys Into Clinton Over Trump, 14-1

In the 2016 election race, the most generous device and diagnostic industry contributors donated heavily to Senate Republicans giving legislative attention to FDA regulatory reforms – Richard Burr, N.C., Kelly Ayotte, N.H., Pat Toomey, Pa. – running close races against Democrat challengers. But while industry primarily backs GOP senators, they also favor Hillary Clinton (D) over Donald Trump (R) with their donations, 14-1.

US Election 2016 Medical Device In Vitro Diagnostics

J&J Pledges To Stop Animal Use In Sales Training

The manufacturer was facing PETA protests in response to a leaked plan to allow pigs to die as part of sales-rep training later this month.

Marketing and Sales Medical Device Commercial

New Clinical Trial Approach For Urgently Needed Therapies Could Be On Horizon

Researchers at RTI Health Solutions, the Massachusetts Institute of Technology, the Medical Device Innovation Consortium, and the US FDA are creating a new statistical methodology for clinical trials that will balance the risk of giving patients an ineffective therapy against the risk of delaying therapy for patients who have few options.

Clinical Trials Research and Development Neurology

Video: Trump v. Clinton On Device Tax

With the US Election Day just weeks away, policy experts representing the Democratic and Republican tickets spoke to AdvaMed 2016 attendees in Minneapolis about the presidential candidates' positions on the medical device excise tax.

US Election 2016 Policy and Regulation Legislation

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UK Accelerated Access Review Can Create A Post-Brexit 'Medtech Powerhouse'

Medical technology stakeholders in the UK will be poring over the detail of the much-anticipated Accelerated Access Review (AAR), the final report of which was released Oct. 24. The initial response from the industry has been positive.

Policy and Regulation Market Access United Kingdom

Interview: Putting The Pieces Together For Combo Products Oversight

Bradley Thompson has been shepherding the Combination Products Coalition for more than a decade. He says the recent spotlight from FDA and other policymakers put on the combo-products space, including in a recent user-fee deal, is a welcome development after a period of neglect. Thompson spoke to Medtech Insight about the numerous reforms in the works and the state of the sector.

Policy and Regulation Medical Device Regulation

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Warning Letter Roundup & Recap – Oct. 25, 2016

No device-related warning letters were released by US FDA the week of Oct. 25.

Device Warning Letters Policy and Regulation

Will EU 'Borderline' Products Know No Borders? New Authorities Could Mean End To Country-By-Country Divergence

The European Commission’s new powers under the Medical Devices and IVD Regulations to decide the regulatory status of products that are on the jurisdictional edge of being a medical device or something else will do away with a legal ruling that has fragmented Europe and caused much frustration for manufacturers.

Europe Medical Devices

FDA Turns Adverse-Event Reporting Scrutiny On Hospitals

The US agency detailed potential adverse-event reporting violations at 15 hospitals in FDA-483 forms that were posted online by FDA to highlight the need to shift to an active, electronic based device surveillance system.

Medical Device Product Safety

FDA Extends Parallel Review Program ‘Indefinitely’

The program, which allows select manufacturers to have their products reviewed simultaneously for FDA approval and Medicare coverage, has been in the pilot stage since 2011. Now it is formally in full implementation mode and the agencies are looking for more manufacturers to participate.

Policy and Regulation Market Access

Interview: Medtech’s Unique Market-Access Routes Demand Tailored Response For EU-Wide HTA

The European Commission is looking at initiatives for employing health technology assessment at the EU level. But the medtech industry is concerned that its own specific market-access routes are being overlooked while the commission focuses too narrowly on solutions more suited to the pharma industry. MedTech Europe’s Yves Verboven explains the industry's case in an interview.

Commercial Market Access

MDIC Project Looks To New P-Value Possibilities

The Medical Device Innovation Consortium is launching a new pilot project with FDA and the Michael J. Fox Foundation to incorporate patient preference into device trials in a ‘scientifically valid way’, according to MDIC CEO Bill Murray, who spoke to MedTech Insight from the AdvaMed 2016 conference in Minneapolis. In our video interview, Murray discusses the project's aim to adjust the statistical design of a study for Parkinson's disease based on patients' willingness to accept risks.

Policy and Regulation Clinical Development and Trials

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Earnings Winners And Losers: ABT, ISRG, JNJ, STJ

Among the first batch of companies to have released their latest quarterly earnings this week are medtech bellwethers Johnson & Johnson, Abbott, St. Jude Medical, Intuitive Surgical and Roche. Here are our picks of who we believe to be the winner, loser and one to watch from this batch.

Financial Reports Companies Commercial

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IVD Earnings Roundup: Roche's Diabetes Division Takes A Dip; Quest Diagnostics; bioMérieux; Danaher

Roche's diabetes business continues to struggle as third quarter results show sales in the division dipped by 3%, while Quest Diagnostics' bottom line took a hit from special charges. bioMérieux and Danaher, which is finalizing its acquisition of Cepheid.

In Vitro Diagnostics Financial Reports

Merit Faces Subpoena Over Marketing

The US Department of Justice is behind the Oct. 19 subpoena, which asks for more information and documents related to Merit’s marketing and promotional practices.

Medical Device Legal Issues

GE Healthcare Pilots New Patient-Focused Mammo Tech

GE Healthcare's latest addition to its Senographe line of digital mammography systems made its debut at France's Gustave Roussy cancer institute this summer. With its design focused squarely on improving patient comfort, the Senographe Pristina is expected to help boost participation in breast screening programs.

Diagnostic Imaging Cancer

Interview: Medtech’s Unique Market-Access Routes Demand Tailored Response For EU-Wide HTA

The European Commission is looking at initiatives for employing health technology assessment at the EU level. But the medtech industry is concerned that its own specific market-access routes are being overlooked while the commission focuses too narrowly on solutions more suited to the pharma industry. MedTech Europe’s Yves Verboven explains the industry's case in an interview.

Commercial Market Access

Turkey To Strengthen Local Medtech; Puts Up $1bn+ For Investing

The Turkish market for medical technologies is expected to see significant growth on the back of new hospital construction, and the government is looking to use its purchasing power to promote local production, but the country’s political environment may pose a challenge to investors.

Turkey Market Access

China Precision Medicine Push Boosting Genomic Business Forays

As the traditional lines between therapeutics and diagnostics become increasingly blurred, genomic testing is growing apace in China, boosted by the country’s national push into precision medicine. Deals and alliances are coming thick and fast as companies jostle for a slice of the growing pie.

China In Vitro Diagnostics

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Interview: J&J Goes Big In Texas

Top Johnson & Johnson executives sat down with Medtech Insight at AdvaMed 2016 to talk about the company's new Center for Device Innovation in Texas, the company's strategic goals in the US and globally, and why they think the US leads in medical device innovation.

Commercial Medical Device Innovation

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Device Week – October 24, 2016

On this week's podcast, Ferdous Al-Faruque and Reed Miller discuss some of their takeaways from the recent AdvaMed 2016 conference. They emphasize mHealth and novel strategies for clinical data-collection as two key themes from the meeting.

Medical Device Clinical Trials

electroCore Stimulates More Promise With Migraine Therapy

New research published in the Journal of Headache and Pain has demonstrated the potential of electroCore's noninvasive vagal nerve stimulation therapy for reducing menstrual migraine attacks by more than a third.

Neurology Clinical Trials

Liquid Biopsy, Particle-Beam Radiotherapy Get 'Moonshot' Commitments

The White House announced 36 new project commitments under its ongoing Cancer Moonshot oncology initiative, including an ambitious project to create an open liquid-biopsy database and a NASA-NCI collaboration to explore the benefits of particle-beam radiotherapy.

Innovation Research and Development

Device Week – October 17, 2016

On this week's podcast, we discussed trends and challenges with adverse-event reporting in the US, lab-developed test marketing, some companion diagnostic data and a look ahead to this week's AdvaMed conference in Minneapolis.

Medical Device In Vitro Diagnostics

Myriad's Ovarian Cancer Test Proves Its Mettle as Tesaro Companion Dx

Myriad’s myChoice HRD test has demonstrated its ability to identify more than twice as many ovarian cancer patients who may benefit from treatment with Tesaro’s drug investigational drug niraparib, compared with patient stratification by germline-BRCA testing alone.

Clinical Trials Research and Development

Mass Spectrometry Makes Inroads Into The Clinical Lab

The use of mass spectrometry in IVD applications looks to be gaining momentum. In this article, Alina Kim, Sunayana Karra and Akash Kundu of Boston Biomedical Consultants report on new developments and innovations showcased at the American Association for Clinical Chemistry Annual (AACC) & Clinical Lab Expo (CLE) annual meeting that took place this summer. Players at the convention exhibited a range of Class I medical devices, research use only liquid chromatography tandem mass spectrometry (LC-MS/MS), matrix-assisted laser desorption/ionization (MALDI-TOF), inductively coupled plasma mass spectrometry (ICP-MS), sample preparation automation platforms, and software solutions.

In Vitro Diagnostics Cancer